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Govts back historic cannabis trial

28 Oct 2014

Medicinal cannabis should be subject to the same safety and efficacy tests as any other drug before being made available on the Australian market, according to the AMA.

As the New South Wales Government works through the details of the nation’s first-ever clinical trial of medicinal cannabis, the AMA has warned against the legalisation of the raw dope plant, or any oils and tinctures made from it, and urged that only fully-tested cannabis-based medicines should be considered for use.

In a significant development for those who argue cannabis is effective in alleviating chronic pain and providing relief from symptoms including nausea and muscle spasms and should be legalised, the NSW Government has secured the support of the Commonwealth and its State and Territory counterparts to trial the use of cannabis for medicinal purposes.

“NSW wants to better understand if and how medicinal cannabis can help improve quality of life for seriously ill patients,” NSW Premier Mike Baird said.

The issue of medicinal cannabis was discussed at a Council of Australian Governments meeting on 17 October following a long-running campaign by advocates who claim it has been effective in helping many patients including those with cancer, terminal illness or conditions such as multiple sclerosis.

Prime Minister Tony Abbott has voiced support for the use of cannabis for medicinal purposes, and has instructed Health Minister Peter Dutton to be “as helpful as he can be” in supporting the NSW trial.

“No one will be tougher on drugs than I will be,” Mr Abbott said. “But, just as we have long used various opiates for medicinal purposes…they play a very important part in pain relief…let’s see what we can do with medical marijuana.”

AMA Victoria President Dr Tony Bartone told the ABC’s Background Briefing program the AMA was not opposed to the use of cannabis for medicinal purposes, but only in forms and applications proven to be effective.

“We are in no form ... looking at the crude plant and legalising the plant for medicinal purposes,” Dr Bartone said, warning that there were great variations in the composition of leaves not commercially grown and harvested that could expose users to harm.

“What we are seeking to do is exactly what any other new medicine would be required to do coming onto the market,” he said – to be tested by the Therapeutic Goods Administration.

The NSW Government has formed a Working Group to advise by the end of the year on the design and scope of the clinical trial, as well as the best way to make safe and effective cannabis products available.

“NSW is playing a leadership role, but our historic agreement to work collaboratively on this significant issue means we have a far greater chance of success,” Mr Baird said.

The AMA has urged that trial focus on cannabis-based pharmaceutical products already being used commercially in overseas markets.

These include medicines that contain a synthetic version of Tetrahydrocannabinol, the main mind altering molecule in cannabis, and the drug Sativex, made from an extract of the cannabis plant. Sativex is already approved by the TGA, but only for use in the treatment of spasticity in muscular sclerosis.

Dr Bartone said the clinical trials could include testing the application of Sativex to a range of other medical conditions.

But the cautious approach urged by the AMA has been criticised by those who claim it is denying relief for thousands unnecessarily.

“I welcome the fact that every Government in the country now recognises that we need to change our approach to medicinal cannabis, but a trial alone is not enough,” Senator Di Natale said.

The Senator said that while it made sense to subject anecdotal claims made for medicinal cannabis to clinical tests, there were many instances where its efficacy was well established and should be approved immediately.

“There is already overwhelming international evidence that medicinal cannabis can provide relief from conditions like nausea, pain and muscle spasms,” he said. “Medicinal cannabis should be made available for those conditions where it has been proven to be effective now, without delay, without trial.”

His urgings appear to have the backing of the Prime Minster, who last month questioned the need for Australian authorities to clinically test medicines already approved by medicine watchdogs in countries such as the US or Europe.